HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)

The HPM38 is a soft contact lens made from polymacon (HEMA-based hydrophilic polymer) for daily wear correction of myopia in non-diseased eyes. It is available in tinted and clear versions, can be prescribed for daily disposable wear or frequent/planned replacement wear with chemical disinfection, and accommodates up to 0.50 diopters of refractive astigmatism.

The proposed device is a spherical polymacon lens with 38% water content, 93% ± 5% light transmission, and refractive index of 1.437. It differs from the predicate in power range (−10.00D to 0.00D vs. −25.00D to +25.00D), color additives (seven vs. four), storage solution (borate buffer vs. saline), oxygen permeability (8.99×10⁻¹¹), and some mechanical properties (modulus, tensile strength, elongation), though these differences do not raise safety concerns.

Testing was performed per ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017, ASTM D882-18, ISO 11981:2017 (care regimen compatibility), ISO 10993-5/10/11/23:2021 (biocompatibility), ISO 17665-1:2006 (sterilization/SAL 10⁻⁶), ISO 11987:2012 (5-year shelf life), and ASTM D4169-22 (simulated transportation).

Both devices are Group I polymacon daily-wear contact lenses with identical material, manufacturing (lathe-cut semi-molded), water content (38%), sterilization method, and biocompatibility. The proposed device has similar indications for use and functionality. Although the predicate offers a broader power range and different color additives and storage solution, these differences are minor and do not pose additional safety or effectiveness concerns; all non-clinical performance and biocompatibility testing confirms the proposed device meets requirements and is compatible with standard lens care regimens.